Procrit 4,000 U/ml 1ml Sd Vial

Manufacturer JANSSEN Active Ingredient Epoetin Alfa Vials(e POE e tin AL fa) Pronunciation e POE e tin AL fa
WARNING: This drug may raise the chance of heart attack, stroke, heart failure, blood clots, and death. Talk with the doctor.People with some types of cancer have died sooner when using this drug. This drug also raised the chance of tumor growth and the tumor happening again in these people. Talk with the doctor.Your doctor will need to watch your blood cell counts and follow you closely to change the dose to match your body's needs. Talk with your doctor.If you will be having surgery, talk with your doctor. You may need to take another drug to keep you from getting blood clots while you get this drug. @ COMMON USES: It is used to treat anemia.It is used to help lower the need for blood transfusions for certain surgeries.It may be given to you for other reasons. Talk with the doctor.
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Drug Class
Erythropoiesis-stimulating agent (ESA)
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Pharmacologic Class
Recombinant human erythropoietin
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Pregnancy Category
Category C
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FDA Approved
Jun 1989
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Epoetin alfa is a medicine that helps your body make more red blood cells. It's like a natural hormone your kidneys produce, called erythropoietin. It's used to treat anemia (low red blood cell count) caused by kidney disease, chemotherapy, or certain other conditions, to help you avoid needing blood transfusions.
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How to Use This Medicine

Proper Use of This Medication

To use this medication correctly, follow your doctor's instructions and read all the information provided. This medication is administered via injection into the fatty tissue under the skin or into a vein by a healthcare professional.

Self-Administration

If you are giving yourself the injection, your doctor or nurse will instruct you on the proper technique. It is essential to follow their guidance to ensure safe and effective use.

Important Handling Instructions

Do not shake the medication.
Do not use the medication if it has been shaken.
Wash your hands before and after handling the medication.
Inspect the solution before use; do not use if it appears cloudy, is leaking, or contains particles.
Check the solution for any color changes; do not use if the color has changed.
Avoid injecting the medication into skin that is irritated, tender, bruised, red, scaly, hard, scarred, or has stretch marks.

Disposal of Needles and Sharps

Dispose of used needles and sharps in a designated disposal box.
Do not reuse needles or other items.
When the disposal box is full, follow local regulations for proper disposal.
If you have any questions or concerns, consult your doctor or pharmacist.

Storage and Disposal

Follow the storage instructions provided for all products.

Missed Dose

If you miss a dose, contact your doctor to determine the best course of action.
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Lifestyle & Tips

  • Maintain adequate iron intake as prescribed by your doctor (often requires iron supplements).
  • Monitor your blood pressure regularly at home, as this medication can raise it.
  • Report any unusual symptoms immediately to your healthcare provider.
  • Do not stop taking the medication without consulting your doctor.

Dosing & Administration

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Adult Dosing

Standard Dose: Highly variable based on indication and patient response. Initial doses typically range from 50 to 150 U/kg 3 times per week (TIW) or once weekly (QW) subcutaneously (SC) or intravenously (IV).
Dose Range: 50 - 60000 mg

Condition-Specific Dosing:

CKD-associated anemia (non-dialysis): Initial: 0.45 mcg/kg (approx. 150 U/kg) IV or SC QW or 0.75 mcg/kg (approx. 250 U/kg) IV or SC Q2W. Target Hb: 10-11 g/dL.
CKD-associated anemia (dialysis): Initial: 50-100 U/kg IV or SC TIW. Target Hb: 10-11 g/dL.
Chemotherapy-induced anemia: Initial: 150 U/kg SC TIW or 40,000 U SC QW. Target Hb: Avoid exceeding 10 g/dL.
Zidovudine-treated HIV-infected patients: Initial: 100 U/kg IV or SC TIW for 8 weeks. Target Hb: Maintain Hb.
Reduction of allogeneic RBC transfusions in surgery: 300 U/kg/day SC for 10 days before surgery, on the day of surgery, and for 4 days after surgery; OR 600 U/kg SC QW for 3 weeks before surgery and on the day of surgery.
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Pediatric Dosing

Neonatal: Not established for routine use; specific dosing for anemia of prematurity may be considered in select cases (e.g., 250 U/kg SC TIW).
Infant: CKD-associated anemia: 50 U/kg IV or SC TIW. Adjust to maintain Hb 10-12 g/dL.
Child: CKD-associated anemia: 50 U/kg IV or SC TIW. Adjust to maintain Hb 10-12 g/dL.
Adolescent: CKD-associated anemia: 50 U/kg IV or SC TIW. Adjust to maintain Hb 10-12 g/dL.
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Dose Adjustments

Renal Impairment:

Mild: No specific dose adjustment required, but dose should be titrated to hemoglobin response.
Moderate: No specific dose adjustment required, but dose should be titrated to hemoglobin response.
Severe: No specific dose adjustment required, but dose should be titrated to hemoglobin response.
Dialysis: Administer IV for patients on hemodialysis. SC administration is also effective. Dose titration based on hemoglobin response.

Hepatic Impairment:

Mild: No specific dose adjustment recommended.
Moderate: No specific dose adjustment recommended.
Severe: No specific dose adjustment recommended.

Pharmacology

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Mechanism of Action

Epoetin alfa is a recombinant human erythropoietin, a glycoprotein that stimulates erythropoiesis (red blood cell production). It binds to erythropoietin receptors on the surface of erythroid progenitor cells in the bone marrow, stimulating their proliferation, differentiation, and maturation into red blood cells. It also induces the release of reticulocytes from the bone marrow into the bloodstream.
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Pharmacokinetics

Absorption:

Bioavailability: SC: 30-50% (variable)
Tmax: SC: 5-24 hours; IV: End of infusion
FoodEffect: Not applicable (parenteral administration)

Distribution:

Vd: Not precisely determined, but distributes primarily to the bone marrow and other erythropoietic tissues.
ProteinBinding: Not extensively protein bound.
CnssPenetration: Limited

Elimination:

HalfLife: IV: 4-13 hours (CKD patients); SC: 18-24 hours (CKD patients), 13-42 hours (cancer patients)
Clearance: Not precisely determined, but primarily cleared by receptor-mediated endocytosis and proteolytic degradation.
ExcretionRoute: Primarily non-renal (catabolism)
Unchanged: <10% (renal excretion of intact drug)
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Pharmacodynamics

OnsetOfAction: Increase in reticulocyte count typically within 7-10 days.
PeakEffect: Peak hemoglobin response typically seen within 2-6 weeks.
DurationOfAction: Effects persist for several days after discontinuation due to the lifespan of red blood cells.

Safety & Warnings

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BLACK BOX WARNING

Increased risk of death, myocardial infarction, stroke, venous thromboembolism, and thrombosis of vascular access. Increased risk of tumor progression or recurrence in patients with cancer. ESAs are not indicated for patients with cancer receiving myelosuppressive chemotherapy when the anticipated outcome is cure. In controlled clinical trials, ESAs shortened overall survival and/or increased the risk of tumor progression or recurrence in patients with breast, non-small cell lung, head and neck, lymphoid, and cervical cancers. To decrease these risks, use the lowest dose of epoetin alfa sufficient to avoid red blood cell transfusions. For patients with chronic kidney disease, the target hemoglobin should not exceed 11 g/dL. For patients with cancer, the target hemoglobin should not exceed 10 g/dL.
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Side Effects

Urgent Side Effects: Seek Medical Help Right Away

Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical attention immediately:

Signs of an allergic reaction: rash, hives, itching, red, swollen, blistered, or peeling skin (with or without fever), wheezing, tightness in the chest or throat, trouble breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat
Signs of high blood pressure: severe headache or dizziness, fainting, or changes in vision
Signs of high blood sugar: confusion, drowsiness, excessive thirst or hunger, frequent urination, flushing, rapid breathing, or fruity-smelling breath
Signs of low potassium levels: muscle pain or weakness, muscle cramps, or an irregular heartbeat
Rapid heartbeat
Shortness of breath, significant weight gain, or swelling in the arms or legs
Weakness on one side of the body, difficulty speaking or thinking, balance problems, drooping on one side of the face, or blurred vision
Confusion
Cool or pale arm or leg
Difficulty walking
Dizziness or fainting
Excessive sweating
Seizures
Extreme fatigue or weakness
Pale skin
Depression

If you experience any of the following symptoms, call your doctor right away, as they may indicate a blood clot:
Chest pain or pressure
Coughing up blood
Shortness of breath
Swelling, warmth, numbness, color changes, or pain in a leg or arm
Difficulty speaking or swallowing

In rare cases, a severe skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis) may occur, which can cause serious health problems and even death. Seek medical help immediately if you notice:
Red, swollen, blistered, or peeling skin (with or without fever)
Red or irritated eyes
Sores in your mouth, throat, nose, or eyes

Other Possible Side Effects

Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other symptoms that bother you or persist, contact your doctor:
Irritation at the injection site
Fever or chills
Headache
Upset stomach or vomiting
Cough
Bone, joint, or muscle pain
Muscle spasms
Mouth irritation or mouth sores
Weight loss
Sleep disturbances
* Common cold symptoms

This list is not exhaustive, and you may experience other side effects. If you have questions or concerns, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
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Seek Immediate Medical Attention If You Experience:

  • Sudden chest pain or shortness of breath
  • Sudden numbness or weakness on one side of the body
  • Sudden severe headache or vision changes
  • Swelling, pain, or redness in an arm or leg (signs of a blood clot)
  • Unusual tiredness or paleness that suddenly worsens (signs of PRCA)
  • Severe allergic reaction (rash, hives, difficulty breathing, swelling of face/throat)
  • Signs of high blood pressure (severe headache, blurred vision, dizziness)
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Before Using This Medicine

Before Taking This Medication: Important Information to Share with Your Doctor

It is essential to inform your doctor about the following conditions before starting this medication:

Any allergies you have, including allergies to this drug, its components, or other substances, and describe the symptoms you experienced.
If you have high blood pressure.
If you have active bleeding.
If you have low levels of vitamins or minerals.
If you have a condition called Pure Red Cell Aplasia (PRCA), a type of anemia.

Additionally, if you are using a multi-dose container, tell your doctor:
If you are pregnant or think you might be pregnant. This medication is not recommended during pregnancy.
If you are breastfeeding. You should not breastfeed while taking this medication and for 2 weeks after your last dose.
If the patient is a premature baby or newborn. This form of the medication is not suitable for premature babies or newborns.

This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist. They will help determine if it is safe to take this medication with your other drugs and health problems. Never start, stop, or change the dose of any medication without consulting your doctor first.
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Precautions & Cautions

Important Warnings and Cautions

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. This drug is derived from human plasma, which is a component of blood, and may potentially contain viruses that can cause disease. Although this medication is thoroughly screened, tested, and treated to minimize the risk of infection, it is crucial to discuss this with your doctor.

Monitoring and Precautions

Regular blood pressure checks are necessary while taking this medication, as it may cause high blood pressure. Adhere to your doctor's instructions for monitoring your blood pressure. Additionally, your doctor may require regular blood tests to ensure safe treatment. It is vital to follow your doctor's guidance on blood work and discuss any concerns with them.

Dosage and Administration

Do not exceed the dosage prescribed by your doctor, as taking more than the recommended amount can increase the risk of severe side effects. If you accidentally take more of this medication than directed, contact your doctor immediately.

Risks and Abuse

This medication increases red blood cell production in the blood. Be aware that misuse or abuse of this type of medication can lead to severe health complications, including stroke, heart attack, and blood clots. If you have any questions or concerns, consult your doctor.

Specific Product Warnings

Multi-dose container: This product contains benzyl alcohol, which can cause serious side effects in newborns and infants, particularly when combined with other medications containing benzyl alcohol. Whenever possible, avoid using products with benzyl alcohol in these age groups. If you have questions, discuss them with your doctor.
Single-use vial: If you are pregnant, plan to become pregnant, or are breastfeeding, inform your doctor. You will need to discuss the potential benefits and risks of this medication to both you and your baby.
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Overdose Information

Overdose Symptoms:

  • Polycythemia (excessively high red blood cell count), which can lead to hyperviscosity syndrome and increased risk of thrombotic events (e.g., stroke, heart attack).

What to Do:

Discontinue epoetin alfa. If polycythemia is severe, phlebotomy (blood removal) may be performed to reduce hematocrit. Symptomatic and supportive care. Call 1-800-222-1222 (Poison Control) or seek immediate medical attention.

Drug Interactions

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Moderate Interactions

  • Thalidomide
  • Lenalidomide
  • Pomalidomide

Monitoring

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Baseline Monitoring

Hemoglobin (Hb)

Rationale: To establish baseline anemia severity and guide initial dosing.

Timing: Prior to initiation of therapy.

Iron status (Ferritin, Transferrin Saturation (TSAT))

Rationale: Adequate iron stores are essential for optimal erythropoiesis and response to epoetin alfa. Iron deficiency is a common cause of ESA hyporesponsiveness.

Timing: Prior to initiation of therapy.

Blood Pressure (BP)

Rationale: Epoetin alfa can cause or exacerbate hypertension.

Timing: Prior to initiation of therapy.

Complete Blood Count (CBC) with differential and platelet count

Rationale: To assess overall hematologic status and rule out other causes of anemia.

Timing: Prior to initiation of therapy.

Renal function (SCr, eGFR)

Rationale: To assess kidney disease severity and guide dosing in CKD patients.

Timing: Prior to initiation of therapy.

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Routine Monitoring

Hemoglobin (Hb)

Frequency: Weekly or bi-weekly until stable, then monthly.

Target: 10-11 g/dL (CKD); <10 g/dL (chemotherapy-induced anemia). Avoid exceeding 11 g/dL (CKD) or 10 g/dL (chemotherapy-induced anemia).

Action Threshold: If Hb rises rapidly (>1 g/dL in 2 weeks) or approaches target, reduce dose. If Hb falls or does not increase, increase dose after ruling out other causes of anemia.

Iron status (Ferritin, TSAT)

Frequency: Monthly or quarterly, or as clinically indicated.

Target: Ferritin >100 ng/mL (CKD), >30 ng/mL (non-CKD); TSAT >20%.

Action Threshold: If iron stores are low, initiate or increase iron supplementation.

Blood Pressure (BP)

Frequency: Regularly (e.g., weekly or bi-weekly) during dose titration, then as per clinical practice.

Target: Individualized, typically <140/90 mmHg.

Action Threshold: If BP increases, initiate or intensify antihypertensive therapy. If uncontrolled, consider dose reduction or temporary interruption of epoetin alfa.

Potassium

Frequency: Periodically, especially in CKD patients.

Target: 3.5-5.0 mEq/L

Action Threshold: Monitor for hyperkalemia, which can occur with rapid increases in erythropoiesis.

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Symptom Monitoring

  • Signs and symptoms of thrombosis (e.g., chest pain, shortness of breath, sudden numbness or weakness, vision changes, swelling/pain in leg)
  • Signs and symptoms of severe allergic reactions (e.g., rash, urticaria, dyspnea, wheezing, hypotension)
  • Signs and symptoms of Pure Red Cell Aplasia (PRCA) (e.g., sudden worsening of anemia, fatigue, pallor)
  • Signs and symptoms of uncontrolled hypertension (e.g., severe headache, blurred vision, confusion, seizures)
  • Signs and symptoms of tumor progression or recurrence (in cancer patients)

Special Patient Groups

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Pregnancy

Category C. Use only if the potential benefit justifies the potential risk to the fetus. Human data are limited.

Trimester-Specific Risks:

First Trimester: Animal studies show adverse effects on fetal development at high doses. Human data are insufficient.
Second Trimester: Limited human data, but no clear evidence of harm. Potential for increased risk of hypertension in the mother.
Third Trimester: Limited human data. Potential for increased risk of hypertension in the mother and potential for fetal polycythemia.
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Lactation

L3 (Moderately Safe). Epoetin alfa is present in human milk. Consider the developmental and health benefits of breastfeeding, the mother’s clinical need for epoetin alfa, and any potential adverse effects on the breastfed infant from the drug or from the underlying maternal condition. Oral absorption by the infant is unlikely due to the large protein nature of the drug.

Infant Risk: Low risk of adverse effects due to poor oral bioavailability of large protein molecules. Monitor infant for adequate weight gain and any unusual symptoms.
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Pediatric Use

Approved for anemia associated with CKD in pediatric patients. Dosing is weight-based. Safety and efficacy in pediatric patients with chemotherapy-induced anemia or HIV-associated anemia have not been established.

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Geriatric Use

No overall differences in safety or effectiveness have been observed between elderly and younger patients. However, elderly patients may be more sensitive to the effects of epoetin alfa, particularly regarding cardiovascular events. Dose titration should be cautious.

Clinical Information

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Clinical Pearls

  • Always ensure adequate iron stores (ferritin >100 ng/mL, TSAT >20%) before and during epoetin alfa therapy, as iron deficiency is the most common cause of ESA hyporesponsiveness.
  • Do not target hemoglobin levels above 11 g/dL in CKD patients or 10 g/dL in cancer patients due to increased risks of serious adverse events.
  • Monitor blood pressure closely, especially during the initial phase of therapy, as hypertension is a common side effect.
  • If a patient becomes resistant to epoetin alfa, investigate other causes of anemia (e.g., iron deficiency, inflammation, infection, blood loss, vitamin deficiencies, PRCA).
  • Administer subcutaneously for most indications outside of hemodialysis patients, as it allows for less frequent dosing and comparable efficacy.
  • Patients should be educated on the signs and symptoms of blood clots and instructed to seek immediate medical attention if they occur.
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Alternative Therapies

  • Darbepoetin alfa (Aranesp) - longer-acting ESA
  • Methoxy polyethylene glycol-epoetin beta (Mircera) - very long-acting ESA
  • Iron supplementation (oral or IV) - often used adjunctively
  • Blood transfusions - for acute, severe anemia or when ESAs are contraindicated/ineffective
  • Hypoxia-inducible factor prolyl hydroxylase inhibitors (HIF-PHIs) like Roxadustat (Evrenzo) - newer class for CKD anemia (not yet widely available in all regions)
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Cost & Coverage

Average Cost: Varies widely by dosage and quantity (e.g., $50-$500+ per vial) per 1ml vial
Generic Available: Yes
Insurance Coverage: Tier 3 or Specialty Tier (often requires prior authorization and step therapy)
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General Drug Facts

If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe and effective treatment, never share your medication with others or take someone else's medication.

This medication is accompanied by a Medication Guide, a patient fact sheet that provides crucial information. It is vital to read this guide carefully and review it again whenever your prescription is refilled. If you have any questions or concerns about this medication, consult your doctor, pharmacist, or other healthcare provider for guidance.

In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When reporting the incident, be prepared to provide detailed information, including the name of the medication taken, the quantity, and the time it occurred.